Mylène Jansen

One-year follow-up after KJD treatment with the KneeReviver 177 9 Non-inferiority Both primary parameters (WOMAC and minimum JSW) were shown to be non-inferior for patients treated with the KneeReviver compared to the Monotubes, as shown in Figure 3. When correcting for baseline values, the minimum JSW change was still non-inferior for the KneeReviver, but (non-) inferiority of the 1-year total WOMAC change was inconclusive (Table 3) as the outer limit of the 90% confidential interval crossed the 10-point non- inferiority level. Figure 3 : Non-inferiority tests for the KneeReviver compared to the Dynamic Monotubes, for the change in (A) the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and (B) the minimum joint space width (JSW). Results are shown both uncorrected (circle) and corrected (diamond) for baseline values. Mean differences with 90% confidence interval are shown. The dotted line indicates the non-inferiority limit. All secondary parameters (VAS pain, SF-36 PCS and MCS) were shown to be non-inferior for the KneeReviver compared to the Dynamic Monotubes, even when corrected for baseline values, as shown in Table 4. Table 4 : Non-inferiority results of the KneeReviver compared to the Dynamic Monotubes for 1-year changes in primary and secondary outcome parameters Non-inferiority limit Baseline correction Difference Conclusion WOMAC total -10 Uncorrected 1.3 (-6.6 to 9.2) Non-inferior Corrected -7.5 (-14.9 to -0.1) Inconclusive JSW minimum -0.56 Uncorrected -0.20 (-0.52 to 0.13) Non-inferior Corrected -0.06 (-0.35 to 0.24) Non-inferior VAS pain -2 Uncorrected -0.1 (-1.2 to 1.0) Non-inferior Corrected 0.7 (-0.3 to 1.6) Non-inferior SF-36 PCS -7 Uncorrected 1.7 (-1.8 to 5.2) Non-inferior Corrected 0.2 (-3.3 to 3.8) Non-inferior SF-36 MCS -7 Uncorrected 1.4 (-1.6 to 4.4) Non-inferior Corrected 0.5 (-2.2 to 3.2) Non-inferior Difference is shown with mean and 95% confidence interval. JSW: joint space width; MCS: mental component scale; PCS: physical component scale; SF-36: Short-form 36; VAS: Visual Analogue Scale; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index.